-
A Study of the Safety and Effectiveness of ADS-5102 in Patients with Multiple Sclerosis and a Walking Impairment
Rochester, MN
This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study of ADS-5102 extended release capsules, an investigational formulation of amantadine, dosed once daily at bedtime for the treatment of walking impairment in MS. ADS-5102 is designed to be administered once daily at bed time, ADS-5102 achieves higher plasma amantadine concentrations in the early morning, sustained throughout the afternoon, and lower concentrations in the evening when patients are sleeping. ADS-5102 is designed to deliver its primary treatment effect during the day, and potentially reduce the adverse events of immediate-release amantadine when the patient is asleep.
-
A Study of the Effectiveness and Safety of Ofatumumab Compared to Teriflunomide for the Treatment of Patients with Relapsing Multiple Sclerosis
Scottsdale/Phoenix, AZ
The purpose of this study is to compare the effectiveness and safety of ofatumumab given by injection every 4 weeks, compared to teriflunomide given orally once daily to patients who have relapsing type (returns and worsens unpredictably) multiple sclerosis.
-
A Study to Evaluate Aspirin for Treating Multiple Sclerosis-related Fatigue
Scottsdale/Phoenix, AZ
The purpose of this study is to determine whether aspirin is effective for treatment of fatigue caused by multiple sclerosis (MS).
-
Best Available Therapy Versus Autologous Hematopoetic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)
Rochester, MN
The purpose of this trial is to compare the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). Participants will be randomized at a 1 to 1 (1:1) ratio. All participants will be followed for 72 months after randomization (Day 0, Visit 0).
-
A Study to Analyze SAR442168 in Participants with Nonrelapsing Secondary Progressive Multiple Sclerosis
Rochester, MN
This study aims to determine the efficacy of SAR442168 compared to placebo in delaying disability progression in NRSPMS and on clinical endpoints, MRI lesions, cognitive performance, physical function, and quality of life.
-
Quantitation of McArdle's Sign and Evaluation of Specificity for Multiple Sclerosis
Rochester, MN
The study is designed to quantitate McArdle's sign, an increase in measurable weakness with neck flexion described in patients with multiple sclerosis, and to determine whether it is or is not specific for multiple sclerosis.
-
Cortical Lesions
Rochester, MN
The hallmark of MS is white matter lesion formation. However, there is increased evidence for gray matter (cortical) involvement and we hypothesize that these cortical lesions are present in patients even in early MS, and may directly determine the location of white matter lesion formation, as well as contribute to cognitive dysfunction in MS. Double inversion recovery (DIR) MRI sequences have been described in multiple adult multiple sclerosis studies to be sensitive for cortical lesions. These images can be obtained on 3 Tesla MRI scanners, using a non-invasive protocol that has been in place at Mayo Clinic. If such cortical ...
-
A Study of Identification of Barriers to Care in Patients with Progressive Multiple Sclerosis
Rochester, MN
The purpose of this study is to gain an understanding of the progressive multiple sclerosis (MS) experience and the meaning patients bring to the experience. By learning about the specific care gaps, barriers, and overall scope of burden, we hope to assess how telemedicine may be effectively used to improve the patient experience and management of progressive MS.
-
Adherence in Pediatric Multiple Sclerosis
Rochester, MN
Disease modifying therapies (DMT) are widely used for children and adolescents with MS. Nonetheless, many pediatric patients continue to relapse and therefore require changes in therapy. We designed this research study to learn more about medication use in children and adolescents with MS. We are also interested in learning what a behavioral feedback intervention can tell us about adherence to medicine. Finally, we hope this research project will inform the way we provide clinical care for children and adolescents with MS.
-
Phase 1 Study to Evaluate the Safety of ATA188 in Subjects With Progressive and Relapsing-Remitting Multiple Sclerosis
Scottsdale/Phoenix, AZ
This is a multicenter, open-label, two-population, single-arm study with a sequential dose-escalation and dose-expansion in adult subjects with progressive forms of multiple sclerosis (MS) and an in adult subjects with relapsed remitting multiple sclerosis (RRMS).
-
A Study to Evaluate 7T Magnetic Resonance Imaging in Multiple Sclerosis
Rochester, MN
The purpose of this study is to compare the effectiveness of 7T imaging to the current conventional imaging (3T) to improve MR sensitivity to the changes of multiple sclerosis. Using FDA-cleared 7T imaging would have a substantial impact on patient management.
-
A Study to Determine the Effectiveness of Early Intensive vs. Escalation Approach to Treat Relapsing/Remitting Multiple Sclerosis
Rochester, MN
The purpose of this study is to determine whether an EHT approach to DMT, defined as use of one of five monoclonal antibodies (alemtuzumab, natalizumab, rituximab, ocrelizumab, ofatumumab) as first-line therapy, is more effective than an escalation of treatment approach in reducing normalized whole brain volume loss measured using MRI in PwRRMS from Baseline to Month 36.
Multi-center pragmatic comparative effectiveness randomized clinical trial with additional-parallel observational cohort.
The DELIVER-MS study seeks to answer the important question: Does early treatment with highly effective DMT improve the prognosis for people with MS? This is an area of significant controversy and no data ...
-
Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis
Rochester, MN
The purpose of this study is to determine the effectiveness and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.
-
A Study to Evaluate Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Patients
Rochester, MN
The purpose of this study is to evaluate, jointly and independently among patients deemed at higher risk vs. lower risk for disability accumulation, whether an "early aggressive" therapy approach, versus starting with a traditional, first-line therapy, influences the intermediate-term risk of disability, and to evaluate if, among patients deemed at lower risk for disability who start on first-line MS therapies but experience breakthrough disease, those who switch to a higher-efficacy versus a new first-line therapy have different intermediate-term risk of disability.FDA-approved multiple sclerosis (MS) disease-modifying therapies (DMTs) target the relapsing phase of MS but have minimal impact once the progressive phase has ...
-
A Study of Environmental Effects on the Intestine Bacteria Commonly Present in Children and Adolescents with Multiple Sclerosis
Rochester, MN
The objective of this study is to understand how commensal (the living together of two organisms in a relationship that is beneficial to one and has no effect on the other) bacteria are associated with MS.
-
A Study of Self-reported Outcomes in Patients with Multiple Sclerosis (MS)
Rochester, MN
The purpose of this study is to determine clinical outcome following treatment for multiple sclerosis (MS) relapse, in patients who were seen at Mayo Clinic.
-
Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis
Rochester, MN
The purpose of this study is to better understand multiple sclerosis (MS) in children and adolescents, to learn if it differs from adult MS and to investigate if genes or environmental exposures or a combination of both put children and adolescents at risk for getting MS.
-
An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab
Scottsdale/Phoenix, AZ
This open-label, rater-blinded extension study will enroll patients who have relapsing-remitting multiple sclerosis (RRMS) and who participated in one of three prior Genzyme-sponsored studies of alemtuzumab [CAMMS223 (NCT00050778), CAMMS323 (NCT00530348) also known as CARE-MS I, or CAMMS324 (NCT00548405) also known as CARE-MS II].
The purposes of this study are:
1. To examine the long term safety and efficacy of alemtuzumab treatment in patients who received alemtuzumab as their study treatment in one of the prior studies.
2. To examine the safety and efficacy of initial alemtuzumab treatment in this study for patients who received Rebif® (interferon beta-1a) as their study treatment in one ...
-
MRI Markers in Multiple Sclerosis
Rochester, MN
The purpose of this study is to develop quantitative approaches of analyzing multimodal MRI acquisitions with the goal to improve cortical lesion detection in all stages in MS, and to understand the interplay between cortical lesions, white matter lesions and functional connectivity network disruptions.
-
A Study to Evaluate Sex Differences in Multiple Sclerosis Spectrum of Demyelinating Disorders
Rochester, MN
The purposes of this study are to explore the association between female sex, reproductive history and clinical phenotypic variability in multiple sclerosis (MS), to explore the association between female sex, reproductive history and radiologic phenotypic variability in MS, and to explore the association between female sex, genetic and environmental interactions in MS.
-
A Study of the Safety and Use of Tecfidera in Routine Medical Practice for the Treatment of Multiple Sclerosis
La Crosse, WI
The purpose of this study is to better identify the long term benefit to risk profile of tecfidera in patients with multiple sclerosis who are prescribed tecfidera under routine clinical care.
-
A Study to Evaluate Patient-Family Views on Pediatric MS Research Needs, Outcomes, and Methods
Rochester, MN
The primary purpose of this study is to determine patients' and families' priorities regarding clinical research studies and perceived barriers to pediatric onset multiple sclerosis (POMS) patients/family participation in research and interventional therapeutic studies.
-
A Study for Long-Term Follow-up of Patients with Multiple Sclerosis who Participated in Previous Study of Alemtuzumab
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the long-term safety, effectiveness, and patient reported quality of life outcomes of treatment with alemtuzumab for patients who have multiple sclerosis and participated in a previous study of alemtuzumab.
-
A Study to Better Understand if Diet and Metabolism are Connected with MS Relapses and Disease Progress in Patients with Pediatric-onset MS
Rochester, MN
The purpose of this research study is to better understand if diet and metabolism are connected with MS relapses and disease progress in patients with pediatric-onset MS.
-
A Study of the Prevalence and Characteristics of Multiple Sclerosis Related Hypothermia
Rochester, MN
The aims of this study are:
-
To assess the prevalence of episodic hypothermia among multiple sclerosis (MS) patients evaluated at Mayo Clinic.
-
To characterize clinical, radiographic, and laboratory features of patients with MS-related hypothermia.
-
A Study of the Effect of MD1003 in Progressive Multiple Sclerosis (SPI2)
Scottsdale/Phoenix, AZ
The purpose of this study is to demonstrate the superiority of MD1003 (300 mg/day) over placebo to clinically improve patients with progressive multiple sclerosis (MS).
-
Assessment of Tecfidera® in Radiologically Isolated Syndrome (RIS)
Rochester, MN
The purpose of this investigation is to systematically study the efficacy of Tecfidera in those individuals who possess incidental white matter anomalies within the brain following a MRI study that is performed for a reason other than for the evaluation of MS (multiple sclerosis).
-
White Matter Hyperintensities in Migraine: A Multi-modal Imaging Project to Classify Disease Pathology
Scottsdale/Phoenix, AZ
The purpose of this research is to better understand brain white matter hyperintensities (WMH) in women with migraine. We will accomplish this by comparing brain imaging and clinical assessments of women with migraine, small vessel ischemic (SVI) disease, and multiple sclerosis (MS).
-
A Biorepository for the Center for Multiple Sclerosis and Autoimmune Neurology
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to establish a repository consisting of clinical information, radiological data, serum, peripheral blood lymphocytes, plasma, cerebrospinal fluid (CSF), urine, stool, DNA and tissue specimens collected from patients who have central nervous system (CNS) inflammatory diseases.
-
Matched Serum and Cerebrospinal Fluid Disease Repository
Rochester, MN
The aim is to establish a repository consisting of clinical information, radiological data, serum, peripheral blood lymphocytes, plasma, cerebrospinal fluid (CSF), and tissue specimens collected prospectively from patients with CNS diseases and controls.